Spherix Global Insights

April 26, 2024

‘Exciting time’: Biologic use in moderate to severe lupus rose 45% since 2021

Use of biologics to treat moderate to severe systemic lupus erythematosus increased 45% between 2021 and 2023, according to recent findings from a market analysis conducted by Spherix Global Insights.

The analysis additionally found that nearly half of moderate-to-severe patients with SLE are currently on a biologic. Meanwhile, among those not currently on a biologic, 73% are considered a candidate for biologic therapy.

“There definitely has been an increase in the use of biologic therapies in the treatment of moderate to severe SLE in the United States in recent years,” Allen P. Anandarajah, MBBS, MS, of the University of Rochester Medical Center, in New York, told Healio Rheumatology.

Spherix Global Insights conducted a patient chart audit of 1,102 patients with moderately to severely active SLE in collaboration with 297 rheumatologists between March 31, 2023, and May 5, 2023. The aim was to determine treatment paradigms for this patient population.

Results showed that 37% of patients were receiving belimumab (Benlysta, GlaxoSmithKline), an increase from 28% in 2022, and from 21% in 2021. According to Spherix, the anticipated efficacy, steroid-sparing capacity and safety profile all served to drive increases in use of this medication. The drug’s recent FDA approval in lupus nephritis may also have contributed to these increases.

Further data demonstrated an increased use of anifrolumab (Saphnelo, AstraZeneca), from 3% of patients in 2022 to 8% in 2023, paired with a decline in rituximab (Rituxan, Genentech) use from 11% of patients in 2021 to 4% in 2023. The Spherix analysis highlighted that the latter trend may be explained by an increase in therapeutic options for SLE, reducing the need for off-label rituximab use.

According to Anandarajah, who was not involved in the Spherix analysis, the relatively sudden availability of FDA-approved therapies for SLE, as well as advances in understanding its pathogenesis, have indeed had an impact.

“This has made it less appealing to use off label use of medications in the management of SLE,” Anandarajah said. “The rapid advances in immunology and, hence, the understanding the pathogenesis of lupus have also contributed to the decrease in need for off label use of medications.”

In addition to the FDA approvals, organizations such as EULAR have included more expansive recommendations for biologic use in their official SLE guidelines. In fact, an upcoming Spherix report will investigate if the 2023 EULAR recommendations to limit steroid use in patients with lupus have been implemented — and if so, are physicians encouraging earlier and more frequent biologic use as a result?

“The recognition of the benefits of the biologics along with the understanding of the science behind the use of these medications make it more appealing to use these medications than the traditional conventional immunosuppressive agents,” Anandarajah said. “The latter may not be proven to be effective in the treatment of lupus — hydroxychloroquine is the only FDA-proven medication among traditional therapies — and the science behind their use in some cases is still not clear.”

‘Numerous side effects’ of steroids

Perhaps the most compelling reason for increased biologic use pertains to steroid sparing. EULAR recommendations have stipulated a target maximum of 5 mg per day of steroids. The goal is to eliminate them altogether.

“There is increasing recognition that steroids have numerous side effects even at low doses,” Anandarajah said. “Although the side effects of steroids have been known for several years, studies in recent years have highlighted the effects of steroids even at low doses and with short durations.”

Data have highlighted the possibility of lowering steroid doses more rapidly in lupus by starting a biologic earlier in the disease course, according to Anandarajah.

“In addition, health care providers are more comfortable with the use of biologics based on their experience in lupus and other rheumatic diseases,” he said.

However, this comfort is not universal.

“One reason providers may not be entirely comfortable with biologics is that SLE is a heterogeneous disease with presentations being quite varied due to different organ involvement,” Anandarajah said.

He additionally noted that many of the recent treatment advances have occurred in lupus nephritis.

“Although this is a very important manifestation, there remains other organ involvement for which the use of biologics is less clear,” Anandarajah said.

However, one additional reason for physician hesitancy regarding biologics has nothing to do with clinical factors.

“Cost remains a major concern, especially outside the United States,” Anandarajah said.

‘Immense hope’ for patients

Whether providers are comfortable with new agents or not, it is difficult to overstate the profound impact that a robust pipeline and biologic therapies have had in the treatment of SLE in recent years.

“It is an exciting time to be a rheumatologist and a lupus specialist,” Anandarajah said. “The newer medications and treatment modalities provide immense hope for our lupus patients. The recognition of the science behind these treatments have led to an immense interest in rheumatology.”

However, despite this optimism, Anandarajah suggested that some caution is warranted.

“The long-term side effects of biologic medications have not been clearly defined, nor have the risks for interactions with other biologic medications for lupus or other diseases,” he said, adding that cost is also a concern.

Anandarajah noted that the looming workforce shortage in rheumatology represents yet another barrier to treatment. Patients cannot benefit from new advances in rheumatology if they cannot see a rheumatologist in the first place.

“Potentially, a bigger concern may be the lack of rheumatologists, with this getting worse over the next few years, in several parts of the country leading to health care disparities,” he said.

Meanwhile, as the field of rheumatology grows more familiar with biologics in SLE, biosimilars have carved out an increasing share of the market.

“Biosimilars are a fast-growing area of the industry,” Anandarajah said. “Although the need for regulation is important, the use of biosimilars in other parts of the world, including Canada and the European countries, suggests that proper planning can help increase competition and decrease the cost of these medications for our patients.”

That said, although biosimilars may ultimately be beneficial for clinical and cost-related reasons, Anandarajah warned rheumatologists of potential bureaucratic pitfalls.

“The wide range of biosimilars and the differences in formulations and coverage by different insurance companies can become an added reason for additional paperwork for physicians,” he said. “This could lead to even more burnout.


Expansion of Biologics Market in SLE. https://www.spherixglobalinsights.com/rheumatology/. Published June 5, 2023. Accessed Feb. 14, 2024.

Source: Healio: https://www.healio.com/news/rheumatology/20240425/exciting-time-biologic-use-in-moderate-to-severe-lupus-rose-45-since-2021